Description of Event or Problem · 0
IT WAS REPORTED THAT DURING USE OF THE INSULIN SYRINGE, UPON ENGAGING THE SYRINGE, THE NEEDLE/CANNULA DISENGAGED FROM THE SYRINGE AND REMAINED IN THE PATIENT'S ARM. THE PATIENT EXPERIENCED PAIN ASSOCIATED WITH THE EVENT. THE NEEDLE/CANNULA WAS SUBSEQUENTLY REMOVED. NO ADDITIONAL INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THE ASSOCIATED LOT/BATCH WAS PERFORMED AND NO DEVIATIONS OR NONCONFORMANCES WERE IDENTIFIED. REVIEW OF RETENTION SAMPLES DEMONSTRATED THAT THE SAMPLES MET RELEASE SPECIFICATIONS. BASED ON THE MANUFACTURING PROCESS AND CONTROLS, SEPARATION OF THE CANNULA FROM THE SYRINGE WOULD REQUIRE MULTIPLE INDEPENDENT MANUFACTURING FAILURES. NO EVIDENCE OF SUCH FAILURES WAS IDENTIFIED DURING REVIEW OF MANUFACTURING RECORDS OR TESTING. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. ALTHOUGH A MANUFACTURING-RELATED ISSUE COULD NOT BE CONFIRMED, IT COULD NOT BE CONCLUSIVELY RULED OUT. THE COMPLAINT WILL BE MONITORED AND TRENDED IN ACCORDANCE WITH THE MANUFACTURER'S QUALITY SYSTEM REQUIREMENTS.